Breastfeeding is recommended by the American Academy of Pediatrics, the World Health Organization and medical professionals worldwide as the preferred method for feeding infants during the first year of life. Human breast milk has significant health benefits that cannot be replicated by infant formula. Specifically, breast milk has been shown to reduce the incidence of infectious diarrhea, respiratory infections, otitis media and childhood obesity. Breastfeeding also has been shown to have health benefits for mothers, by reducing the risk of postpartum bleeding and anemia. Risks are also lowered for ovarian and premenopausal breast cancer. Further, postpartum weight loss is enhanced in breastfeeding mothers. Other benefits of breastfeeding include its comforting effect upon both mother and infant. For these reasons, many health professionals have determined that breastfeeding produces healthier, happier, infants and mothers, which is why breastfeeding is being promoted worldwide as a public health measure.
No infant formula can completely replicate the composition and benefits of human breast milk. Therefore, any proportion of breast milk in an infant's diet is preferable to no breast milk at all. Health professionals strive to encourage new mothers to provide their infants with the highest proportion of breast milk possible during the first year of life.
Unfortunately, there are many challenges to implementing breastfeeding. Breastfeeding requires constant attendance by the nursing mother every 1-2 hours, around the clock, for the baby's first 1-2 months of life, and approximately every 3-4 hours for the next 9 months of life. Furthermore, newborns may require up to 45 minutes per feeding. Nursing mothers must get adequate sleep, nutrition and hydration to maximize their milk production. For mothers with twins, triplets, or greater multiple births, the demand on the nursing mother's time is even greater. Some mothers have physical limitations which inhibit breastfeeding, such as inverted or sore nipples. Other mothers simply cannot make enough milk for their infants, and find that they must supplement their milk production with formula. In other cases, the physical limitations lie with the infant, namely premature or low birth weight infants who have weak suckling abilities, “floppy” infants with poor muscle tone, “tongue tied”, cleft lip or cleft palate infants who cannot create a seal between their mouth and the nipple. In addition to physical limitations, societal norms create obstacles to breastfeeding. Breastfeeding in public is often prohibited, which limits mothers to breastfeeding at home.
Consequently, despite many government programs and initiatives to promote breastfeeding, most American women abandon breastfeeding long before the recommended first year of life. Studies have shown that only two-thirds of mothers breastfeed their infants when they leave the hospital, and at six months, that number shrinks to one third.
The alternatives to fulltime breastfeeding are either formula feeding, or feeding expressed human breast milk by bottle. Breast milk can be expressed, or released from the mother's lactating breasts, by massaging the breast by hand, or by the application of manual or electromechanical pumping equipment acting upon the breasts, both of which are commonly available in the domestic U.S. market.
For a woman to continue lactating a sufficient volume of milk, she must empty her breasts according to the feeding schedules and milk quantities demanded by an infant. Therefore, mothers who work outside of the home must stop working approximately every two and a half hours to pump breast milk in order to maintain an adequate milk supply. When pumping equipment is employed, it takes approximately 30 minutes for a mother to set up the pumping equipment, undress, pump, and perform cleanup. Because most current breast milk pumping and collection systems require a mother to frontally undress, a private setting is usually deemed necessary. This process, which must be continually repeated every two and a half hours is isolating, cumbersome, and extremely disruptive during work. Additionally, many breast pumping devices require the mother to use both of her hands to keep the equipment in position for efficient pumping, which prevents the mother from being able to perform other tasks as may be required in the workplace. The initial and recurring costs involved with using pumping equipment is a further factor which may limit the attractiveness of continuing to breastfeed.
Presently, few breast pumping devices allow for true hands-free operation. Most breast pump devices have hand-held funnel-shaped nipple adaptors, which allow suction to be applied to the nipples for milk expression. The nipple adaptors are then attached to baby bottles for milk collection. Examples of these types of devices are shown in U.S. Pat. Nos. 6,575,202 (Laford), 5,295,957 (Aida et al.), 5,071,403 (Larsson) and 5,358,476 (Wilson). Typically, suction is provided to these devices by a table-top electric pump. The pump can be situated nearby on the floor or on a tabletop, and the suction connection is made with small diameter (as little as 0.125″ I.D.) flexible plastic tubing to facilitate the relatively low pressure, high volume, suction that is required to pull the woman's breast into the adaptor. A typical pump that is cylinder-actuated operates as a closed system, trapping a volume of air in the adaptor. When the woman's breast is pressed into the adaptor, it seals itself against the sides of the adaptor and forms the enclosed space in front of the nipple. When suction is applied, the malleable breast is pulled into the adaptor and toward the opening at the end of the funnel-shaped adaptor. A typical pump's cylinder, with an interior volume of several cubic inches, cycles back and forth repetitiously, completing an in-out “throw” over the course of a second or two, to create a massaging pulling rhythm upon the woman's breasts by alternating positive and negative pressure. This rhythm stimulates the mother's milk to be released, or “letdown,” whereupon it flows, and is eventually collected in the manner already described.
Many of the vacuum source pumps are very durably constructed, provide significant suction, and since they are commonly used in hospital maternity wards to help new mothers stimulate milk production for their newborns, the pumps are constructed so that the major components can be disassembled and thoroughly cleaned between patients, for re-use. There are also a variety of other powered and manual pump types available on the market and well known in the pumping arts, ranging from very simple compact hand pumps, to innovative electromechanical concepts. The predominant and preferred pumps known to those skilled in the art for long term use are consumer versions of the very effective hospital grade pumps. For cost considerations, these pumps are not constructed to allow such thorough cleaning as the true hospital grade pumps, and so are intended for single users. However, since their performance characteristics are considered by professionals in the art of breastfeeding to be on a par with the pumps utilized in hospitals, these more substantial consumer pumps are commonly referred to as “hospital grade.”
Certain pumps utilize an electromechanical construction with an impeller or other means that creates a constant suction with a pressure relief mechanism or valve, wherein the pump builds up negative pressure to some predefined, preset or adjustable maximum, and then a relief valve or other means releases the negative pressure, so that during the cycle the vacuum pressure peaks, then is relieved and suction drops and approaches a more close-to-neutral negative pressure measurement. In these constant suction pumps, the negative pressure builds up, is relieved, and then the cycle repeats itself as the relief mechanism shuts itself off again and negative pressure begins to build up again.
In these constant suction systems, the tendency for milk to migrate through the vacuum lines is great, and a key element often utilized to protect the pump's works from contamination is an inline porous filter in the vacuum feed line, which is well known in the art. These filters allow air to pass through, but collect most or all of the milk that reaches them. These filters can then be regularly cleaned or replaced when they have collected too much milk, allowing adequate air passage to achieve the desired suction. These pumps can be cost effective and efficient pumps for users who must pump frequently.
Many pumps during a typical cycle create negative pressure, and then alternately return toward a neutral pressure, which may give the user the sense of an alternating negative and positive pressure, even though no positive pressure may actually be measured during the majority of cycles from the pump. The benefit of these systems is that the adaptor, once placed against the breast, has a tendency to hold onto the breast, especially if the pump's cycle, once engaged and some air is purged from the trapped enclosure, alternates between strong negative pressure and weak negative pressure, but never alternates to all the way back to a neutral or positive pressure. If substantial positive pressure was actually introduced into this cycle, there would be a tendency to “blow” the adaptor off the breast, resulting in a disruption of the pumping rhythm, and possibly causing small amounts of milk in the adaptor to leak from the device and onto the user, rather than migrate into the collection container. For these reasons, during the initial engagement of the pumping cycle and the purging of excess air from the enclosure, and for the duration of the pumping session, a secure seating of the adaptors to the breasts is preferred, to establish a consistent and relaxing rhythm which most mothers find essential to letting down their milk, which does not usually come for a minute or more after the pumping has begun. Thus, even though a pump, once engaged for a pumping session may never reach into the positive pressure range on an atmospheric scale, the valving means adapted for such pumps are usually weak enough so that simply the weight of expressed milk which builds up within the enclosure can force itself through.
For alternating cycle pumps, some combination of valving and relief features are especially important to allow the volume of air trapped in the enclosure to constantly adjust itself, as the propensity for a malfunction to cause the adaptor to “blow” off the breast is more common with these pump types. What is common to all pumps, however, is that they of necessity, to stimulate the mother to release milk somewhat replicate the suckling of an infant, and so the sensation that must be created by the pump alternates between a somewhat strong negative pressure, and a weak or non-existent negative pressure, with a complete alternating cycle usually lasting only a second or two. These various pump systems, during a single cycle, alternate between generating a stronger negative pressure until a peak, and then the mechanism begins to cycle in the other, or “positive,” direction, by whatever mechanical means, thereby relieving negative pressure within the subject enclosure. In this context, “positive pressure” does not necessarily refer to an objective measure of pressure within the device, relative to the surrounding atmospheric pressure.
Different pumps have different cycling characteristics, and differ from one another in achievable pressures. Different users may differ in their preferences for the specific rhythmic characteristics of various pumps on the market, but those skilled in the art generally agree that the more substantial “hospital grade” pumping equipment that provides more negative pressure and a more reliable and consistent suction and rhythm provides the most benefit for mothers whose circumstances require that they must for an extended period frequently utilize a breast pump. While many of these devices provide good suction and milk collection characteristics, hands-free operation is not possible because of the need to use the hands to hold the device against the breast during milk collection. Furthermore, because of the size and shape of these devices, the user must be frontally undressed to pump milk.
Some manufacturers have attempted to make pumping more discreet and hands-free by securing the assembly of adaptors, bottles and hoses with specialized straps, brassieres and harnesses. These types of devices are represented in U.S. Pat. Nos. 6,004,186 (Penny) and 6,379,327 (Lundy). However, since the entire assembly of adaptors, bottles and hoses is relatively large and cumbersome, in practice these devices still require a woman to undress to put on and to remove these devices with each use. Furthermore, as the bottles fill with milk, they may require some support of the bottle assembly system by hand.
U.S. Pat. No. 6,440,100 (Prentiss) presents a hands-free option which uses a low profile nipple cap held in place by a nursing brassiere. The nipple cap is placed over the nipple and a tube, for both vacuum supply and milk collection, extends from below the nipple cap to a collection container. A vacuum source, such as an electric pump, draws the milk from both breasts into the collection container which hangs below the brassiere. While this solution goes a long way towards providing a hands-free design, the placement of the collection container outside of the brassiere is cumbersome and unwieldy when placing and removing this device.
Also, while Prentiss attempts to provide an unobservable and virtually unnoticeable low profile application beneath normal clothing, the Prentiss design raises other issues. Namely, Prentiss attempts to minimize the profile of the nipple cap by placing the vacuum source directly below the nipple. With this design, when suction is applied, the nipple is drawn downward, which tends to inhibit the flow and expression of milk by drawing the nipple onto the vacuum source or by pinching the milk ducts. Ideally, the nipple should be drawn forward to create the smooth and unobstructed action necessary to trigger the expression of milk. Elongation of the nipple and forward suction is the same as that applied by a suckling infant. Therefore, while Prentiss is likely to be effective for passive milk collection or for women with an abundant milk supply who require little suction to release their milk, its design may result in the failure to trigger the milk expression reflex in many women.
A hands-free pump is manufactured by Whisper Wear, Inc., of Marietta Ga. This device is comprised of a dome-shaped body having a self-contained AA battery powered pump. The rear of the body has a funnel adaptor for placement of the nipple. This device is only several inches in diameter and can be placed easily and discreetly within a regular brassiere. A collection bag attaches to the device and visibly hangs below the brassiere. If two devices are used at once, two bags are necessary for milk collection. While less cumbersome and completely portable when compared to the other solutions discussed herein, the use of the hanging plastic milk bags employed by the Whisper Wear device is unwieldy. Additionally, the system is expensive when the up front costs of the device are considered along with the ongoing costs of disposable batteries and single-use collection bags. This renders the system uneconomical for many mothers. But perhaps the greatest shortcoming of the Whisper Wear device when compared to the larger tabletop electric pumps is the strength of the suction it applies to the breast. The problem is one of scale. Once the Whisper Wear pump is placed over the nipple, the total volume of air trapped inside the mechanism is quite small, usually less than one cubic inch on average. Furthermore, the housing of the device limits the “throw” within this cavity to less than an inch, resulting in a much lower displacement, and therefore, a much less vigorous pumping action for milk expression. Also, being an integrated mechanical pump and battery, coupled with the weight of a suspended milk reservoir, the Whisper Wear devices are much heavier when worn hands-free within a brassiere than the adaptor and bottle assemblies discussed previously, which use tabletop electric pumps. During use, the weight and placement of the Whisper Wear devices within the bra can pinch some milk ducts, while simultaneously emptying others. These characteristics make the Whisper Wear pump inadequate for many women as a full time pumping solution. A stronger pump is necessary for some women to relieve obstructed milk ducts and empty their breasts completely.
U.S. Pat. No. 4,857,051 to Larsson (“Larsson”) discloses a breast pump device having a hood member with a first funnel end and a second end which communicates with a collection chamber and a vacuum line. Larsson further discloses a breast pump device having a valve mechanism which closes a collection chamber when a vacuum is applied to a hood member and which opens the collection chamber when the vacuum is removed. Larsson further discloses a baffle in the hood member where the baffle is formed by a separation wall located between the second end of the hood member and the vacuum line. The baffle is located directly in front of a user's nipple when her breast is placed against the hood member in use of the pump device and prevents milk from reaching the vacuum line. Larsson does not disclose a breast pump collection device having a breast adaptor with a valve assembly wherein the valve assembly comprises a baffle structure configured to prevent the back flow of milk into the vacuum line when large amounts of aerated milk flow up into an overflow chamber before the suction of a negative pumping cycle is released, without milk entering the vacuum line.
U.S. Pat. No. 4,929,229 to Larsson (“Larsson”) discloses another breast pump device having a hood member with a first funnel end and a second end which communicates with a collection chamber and a vacuum line. A downwardly extending separation wall forms a baffle located between the second end of the hood member and the vacuum line. Milk that is expressed into the hood member is then blocked by the separation wall or baffle from reaching the vacuum passage. Again, this baffle is located directly in front of a user's nipple when her breast is placed against the breast shield assembly and prevents milk from reaching the vacuum passage. Larsson here does not disclose a breast pump collection device having a breast adaptor with a valve assembly wherein the valve assembly comprises a baffle structure configured to prevent the back flow of milk into the vacuum line when large amounts of aerated milk flow up into an overflow chamber before the suction of a negative pumping cycle is released.
U.S. Pat. No. 6,652,484 to Hunckler, et al. (“Hunckler”) discloses a breast pump device having a downwardly extending separation wall forming a baffle located between a second end of a breast hood or breast shield assembly and a vacuum passage. Milk that is expressed into the breast shield assembly is then blocked by the separation wall or baffle structure from reaching the vacuum passage. Again, this baffle is located directly in front of a user's nipple when her breast is placed against the breast shield assembly and prevents milk from reaching the vacuum passage. Hunckler does not disclose a breast pump collection device having a breast adaptor with a valve assembly wherein the valve assembly comprises a baffle structure configured to prevent the back flow of milk into the vacuum line when large amounts of aerated milk flow up into an overflow chamber before the suction of a negative pumping cycle is released.
Therefore, it would be desirable to have a pumping system that is hands free, but that is also easy to assemble, disassemble and clean, and reassemble, and to position under normal clothing without the need to undress or to don complicated and overtly visible harness systems, which pumping system can be adapted to function with a wide variety of the more substantial “hospital grade” pump technologies available.
Passive milk collection is also an area of breastfeeding worth addressing. Passive milk collection extends from the natural “letdown” reflex a woman experiences when an infant “latches” onto a woman's breast and begins nursing. When a breast is stimulated to release milk by a nursing infant, or through pumping a single breast, the second breast also naturally begins to release milk. If the milk being expressed from the second, unattended breast is not collected, the amount of milk that is wasted can range from a negligible percentage to as much as a third of a mother's milk supply. Therefore, due to this “letdown phenomenon,” a great deal of milk that could be collected and fed to the infant via bottle is currently being wasted by most breastfeeding mothers. Presently, the predominant practice among nursing mothers to address this phenomenon is the use of absorbent, disposable or reusable pads placed inside the bra cup of the unattended breast.
Therefore, it would be desirable to have a device that can collect passively released milk from the unattended breast for subsequent feeding.
Breastfeeding physically challenged infants presents its own special problems. A significant number of infants with physical challenges, such as floppy infants, premature infants, or infants with cleft lip/palate have difficulty initiating the letdown reflex on their own. These challenges may be due to a lack of adequate strength to latch onto the breast, difficulty creating sufficient suction, or a lack of focused attention. As a result, many physically challenged infants cannot derive sufficient caloric intake for their sustenance from natural breast feeding. It would therefore be desirable to have a compact, hands-free device which can be used to pump one breast, thereby initiating the letdown reflex from both breasts, for the purpose of allowing a mother to hold and nurse a physically challenged infant from the opposite breast.
Consequently, a need exists for a breast milk collection device which can fit completely within a woman's standard brassiere. Such a device would be less likely to interfere with breastfeeding from the opposite breast and avoid the isolating, disruptive, and sometimes embarrassing need to disrobe to pump breast milk, which device can be adapted to function with a wide variety of the more substantial “hospital grade” and other pump technologies available.
A need also exists for a breast milk collection device that is both sufficiently powerful and hands-free.
A further need exists for a breast milk collection device that provides a viable solution for passive milk collection while simultaneously breastfeeding.
A need also exists for a breast milk pumping and collection device which can help compromised infants breastfeed.
Furthermore, a need exists for a breast milk collection device having reduced maintenance requirements provided by inhibiting the back flow of breast milk into the pump or suction lines.
A further need exists for a breast milk collection device having a vacuum pressure hose inlet port that is located apart from the path of milk expressed from the breast during the pumping operation, whereby the inlet port is not in direct contact with the expressed milk.
An additional need exists for a breast milk collection device having an overflow chamber and baffle combination that when the flow of breast milk is large in a single cycle, milk flows into the overflow chamber from a drip tube at an end of the breast adaptor before suction is released. When the overflow chamber is used, the mixture of milk and air in the drip tube can cause turbulence in the liquid, causing the milk to bubble and become airborne due to the suction force. The baffle in the overflow chamber deflects or redirects any airborne mist of milk that is pulled in the direction of the vacuum hose inlet port. In this way, bacteria-forming milk is kept from entering the pump's inner works and suction hoses.
A need also exists for a hands free, concealable and ergonomically shaped breast milk collection device that can be adapted for use with an internal or inline filter system for use with a constant suction pump, so that air is allowed to pass through the filter, while milk is trapped, protecting the pump's inner works.
A further need exists for a hands free, concealable and ergonomically shaped breast milk collection device that can be supported by an ordinary bra, which also integrates a vacuum barrier, to allow use of the device with pumps that require separation of the air in the vacuum lines and pump works from the air in direct communication with the breast and milk collection means.
Yet another need exists for a breast milk collection device whose several parts are easily manually disassembled for cleaning and decontamination, and are subsequently easy to manually reassemble in only a single, correct configuration for proper use of the collection device.
A further need exists for a hands free, concealable and ergonomically shaped breast milk collection device wherein a tortuous path is provided between the application of suction pressure and the breast for the purpose of preventing the backflow of expressed milk into the suction pressure hose or related suction pump mechanism.
Still another need exists for a breast milk collection device having an adaptor connected between the collection device vacuum hose and the outlet hose of a vacuum pump system that allows the vacuum hose and the outlet hoses to be properly connected even where the two hoses have different inner or outer diameters.
Yet another need exists for a breast milk collection device having a source of vacuum pressure applied to the breast to produce the expressions of breast milk, wherein the source of vacuum pressure is totally isolated from the flow path of the milk from the breast into the collection device reservoir.
The foregoing reflects the state of the art of which the inventors are aware, and is tendered with a view toward discharging in part the inventors' acknowledged duty of candor, which may be pertinent to the patentability of the present invention. It is respectfully stipulated, however, that the foregoing discussion does not teach or render obvious, singly or when considered in combination, the inventors' claimed invention.